AZILECT

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

RASAGILINE AS MESYLATE

Commercializzato da:

TEVA ISRAEL LTD

Codice ATC:

N04BD02

Forma farmaceutica:

TABLETS

Composizione:

RASAGILINE AS MESYLATE 1 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Gruppo terapeutico:

RASAGILINE

Area terapeutica:

RASAGILINE

Indicazioni terapeutiche:

Azilect is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa)or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.

Data dell'autorizzazione:

2014-12-31

Foglio illustrativo

صيخشت بجي !ةمتعلا يف ةيودأ لوانت زوجي
لا ةيئاودلا ةعرجلا نم دكأتلاو ءاودلا
عباط تاراظنلا عض .ءاود اهيف لوانتت ةرم لك
يف
.كلذ رملأا مزل اذإ ةيبطلا لامعتسإ لوح ةيفاضإ ةلئسأ كيدل ترفوت
اذإ
.يلديصلا وأ بيبطلا رشتسإ ،ءاودلا اذه
ةيبناجلا ضارعلأا )4
ببسي دق ءاودلا اذه لامعتسإ نإ ،ءاود
لكب امك
نم شهدنت لا .نيلمعتسملا ضعب دنع ةيبناج
ً
اضارعأ
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق
:اذإ بيبطلل
ً
لااح هجوتلا بجي
،يرسق كولس لثم ةذاش تايكولس كيدل تروطت
∙
وأ قافنلإا ،رامقلا ىلع نامدلإا
،ةيساوسو راكفأ
عفاد نع مجان كولس ،هيف غلابم لكشب
ءارشلا
راكفأ وأ داتعملا نع ةدئاز ةيسنج ةبغرو
)ةيعافدنإ(
)عفاودلا يف مكحتلا تابارطضإ( ةديازتم
ةيسنج
.)»ءاودلا لامعتسإ لبق« ـ 2 ةرقفلا رظنأ(
.)نايذه( ةدوجوم ريغ ءايشأ عمست وأ ىرت
تنك ∙
مدع ،ةنوخس ،نايذه نم جيزم يأ كيدل دجو
∙
.)نينوتوريسلا ةمزلاتم( قرعت وأ فاجترإ
،ةحار
ةيدلج تاريغت تظحلا اذإ بيبطلل هجوتلا
بجي
ةدئاز ةروطخ كلانه نوكت دق هنلأ كشلل
ةريثم
اذه لامعتسإ دنع )امونلايم( دلجلا ناطرس
ثودحل
.)"ءاودلا لامعتسإ لبق" ـ 2 ةرقفلا رظنأ(
ءاودلا
ةيفاضإ ةيبناج ضارعأ رهظت ضارعأ ـ
ً
ادج ةعئاش ةيبناج ضارعأ
:ةرشع نيب نم دحاو لمعتسم نم رثكأ ىدل
)
dyskinesia
( ةيدارإ لا تاكرح ∙
عادص ∙ ىدل رهظت ضارعأ ـ ةعئاش ةيبناج

Scheda tecnica

1
Azilect- Tablets_SPC-
Notif
_11-2020_NS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AZILECT 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets, debossed with
“GIL” and “1” underneath on one side
and plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AZILECT is indicated for the treatment of idiopathic Parkinson’s
disease as monotherapy (without
levodopa) or as adjunct therapy (with levodopa) in patients with end
of dose fluctuations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of rasagiline is 1 mg (one tablet of AZILECT)
once daily, to be taken with or
without levodopa.
_Elderly_
No change in dose is required for elderly patients (see section 5.2).
_Hepatic impairment_
Rasagiline is contraindicated in patients with severe hepatic
impairment (see section 4.3). Rasagiline use
in patients with moderate hepatic impairment should be avoided.
Caution should be used when initiating
treatment with rasagiline in patients with mild hepatic impairment. In
case patients progress from mild to
moderate hepatic impairment rasagiline should be stopped (see section
4.4 and 5.2).
_Renal impairment_
No special precautions are required in patients with renal impairment.
_ _
_Paediatric population_
The safety and efficacy of AZILECT in children and adolescents have
not been established. There is no
relevant use of AZILECT in the paediatric population in the indication
Parkinson’s disease.
Method of administration
For oral use.
AZILECT may be taken with or without food.
2
Azilect- Tablets_SPC-
Notif
_11-2020_NS
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Concomitant treatment with other monoamine oxidase (MAO) inhibitors
(including medicinal and
natural products without prescription e.g. St